Submission for OMB review; Comment Request; Parental Knowledge, Attitudes, and Behaviors Related to Pediatric Cardiovascular Health, 59557-59558 [E9-27688]
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59557
Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices
regulated solely under section 361 of the
PHS Act as described in § 1271.10. The
number of respondents and total annual
responses are based on the BPD reports
and HCT/P deviation reports FDA
received in fiscal year (FY) 2008. The
number of licensed manufacturers and
total annual responses under 21 CFR
600.14 include the estimates for BPD
reports submitted to both CBER and
CDER. Based on the information from
industry, the estimated average time to
complete a deviation report is 2 hours.
The availability of the standardized
report form, Form FDA 3486, and the
ability to submit this report
electronically to CBER (CDER does not
currently accept electronic filings)
further streamlines the report
submission process.
CBER has developed an addendum to
Form FDA 3486. The web-based
addendum 3486A provides additional
information when a BPD report has been
reviewed by FDA and evaluated as a
possible recall. The additional
information requested includes
information not contained in the Form
FDA 3486 such as: (1) Distribution
pattern, (2) method of consignee
notification, (3) consignee(s) of products
for further manufacture, (4) additional
product information, (5) updated
product disposition, and (6) industry
recall contacts. This information is
requested by CBER through e-mail
notification to the submitter of the BPD
report. This information is used by
CBER for recall classification purposes.
At this time Addendum 3486A is being
used only for those BPD reports
submitted under § 606.171. CBER
estimates that 5 percent of the total BPD
reports submitted to CBER under
§ 606.171 would need additional
information submitted in the
addendum. CBER further estimates that
it would take between 10 to 20 minutes
to complete the addendum. For
calculation purposes, CBER is using 15
minutes.
Activities such as investigating,
changing standard operating procedures
or processes, and follow-up are
currently required under 21 CFR parts
211, (approved under OMB control
number 0910–0139), part 606 (approved
under OMB control number 0910–0116),
part 820 (approved under OMB control
number 0910–0073), and part 1271 are
approved under OMB Control No. 0910–
0543 and, therefore, are not included in
the burden calculation for the separate
requirement of submitting a deviation
report to FDA.
FDA estimates the burden of this
collection of information as follows:
ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR
Section
FDA Form
Number
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
600.14
3486
51
7.78
397
2.0
794
606.171
3486
1,533
28.78
44,125
2.0
88,250
1271.350(b)
3486
84
2.64
222
2.0
444
3486A2
77
28.65
2,206
0.25
551.5
Total
90,039.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Five percent of the number of respondents (1,533 x 0.05 = 77) and total annual responses to CBER (44,125 x 0.05 = 2,206).
Dated: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–27716 Filed 11–17–09; 8:45 am]
BILLING CODE 4160–01–S
5 CFR 1320.5 (General requirements)
Reporting and Recordkeeping
Requirements:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSKH9S0YB1PROD with NOTICES
Submission for OMB review; Comment
Request; Parental Knowledge,
Attitudes, and Behaviors Related to
Pediatric Cardiovascular Health
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of
Health has submitted to the Office of
Management and Budget (OMB) a
request to review and approve the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on Wednesday, July 29, 2009,
VerDate Nov<24>2008
16:30 Nov 17, 2009
Jkt 220001
Volume 74, Number 144 and allowed
60-days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
Final Rule requires that the agency
inform the potential persons who are to
respond to the collection of information
that such persons are not required to
respond to the collection of information
unless it displays a currently valid OMB
control number. This information is
required to be stated in the 30-day
Federal Register Notice.
Proposed Collection: Describe the
proposed information collection activity
as follows. Include: Title: Parental
Knowledge, Attitudes, and Behaviors
Related to Pediatric Cardiovascular
Health; Type of Information Collection
Request: New; Need and Use of
Information Collection: Coinciding with
the release of the Integrated Pediatric
Cardiovascular Risk Reduction
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Frm 00038
Fmt 4703
Sfmt 4703
Guidelines, the National Heart, Lung,
and Blood Institute (NHLBI) will
conduct a national public awareness
campaign to help parents understand
that risk for cardiovascular disease
(CVD) begins in childhood, and to
engage them in encouraging healthy
habits in their children to promote heart
health and reduce their children’s CVD
risk now and as they grow. Currently,
little is known about parental
knowledge, attitudes, and behaviors
related to heart health in children.
Serving as a baseline for evaluation of
NHLBI’s outreach activities related to
the campaign, this study seeks to learn
the following: (a) Parents’ awareness of
cardiovascular disease risk factors in
children and knowledge of what to do
for risk reduction, (b) parents’ level of
efficacy toward taking action to promote
cardiovascular health and reduce risk
factors, and (c) parents’ behaviors
related to cardiovascular health. The
findings will provide valuable
information that will enable NHLBI to
identify the gaps in knowledge and
awareness and target specific
E:\FR\FM\18NON1.SGM
18NON1
mstockstill on DSKH9S0YB1PROD with NOTICES
59558
Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices
information in communications with
parents. NHLBI will also be able to
determine parents’ efficacy related to
the actions needed to promote their
children’s heart health, allocating
resources for the campaign to provide
support to overcome perceived barriers;
Frequency of Response: One-time
survey; Affected Public: Individuals or
households; and Type of Respondents:
Parents and caregivers of children ages
0–7. The annual reporting burden is as
follows: Estimated Number of
Respondents: 1,175; Estimated Number
of Responses per Respondent: 1;
Average Burden Hours Per Response:
.167; and Estimated Total Annual
Burden Hours Requested: 196.23. There
are no Capital Costs, Operating Costs,
and/or Maintenance Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Amy
Pianalto, National Heart, Lung, and
Blood Institute, NIH, 31 Center Drive,
Building 31A, Room 4A10, Bethesda,
MD 20892; or call non-toll-free number
301–594–2093 or e-mail request,
including your address, to
pianaltoa@nhlbi.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
VerDate Nov<24>2008
16:30 Nov 17, 2009
Jkt 220001
Dated: October 30, 2009.
Amy Pianalto,
Technical Writer, Office of Communications
and Legislative Activities, NHLBI, National
Institutes of Health.
[FR Doc. E9–27688 Filed 11–17–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0535]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; ‘‘Real Time’’
Surveys of Consumers’ Knowledge,
Perceptions, and Reported Behavior
Concerning Foodborne Illness
Outbreaks or Food Recalls
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
‘‘Real Time’’ surveys of consumers’
knowledge, perceptions, and beliefs
concerning foodborne illness outbreaks
or food recalls.
DATES: Submit written or electronic
comments on the collection of
information by January 19, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
‘‘Real Time’’ Surveys of Consumers’
Knowledge, Perceptions, and Reported
Behavior Concerning Foodborne Illness
Outbreaks or Food Recalls—Federal
Food, Drug, and Cosmetic Act/Section
903(d)(2)(C)—(OMB Control Number
0910–NEW)
I. Description
FDA communicates with consumers
about food recalls directly, on its own
Web site, and through various mass
media channels, such as television and
newspapers, during a foodborne illness
outbreak or food recall. In these
communications, FDA typically
identifies the implicated food, the
symptoms of the foodborne illness at
issue, any subpopulations at elevated
risk of infection or illness, and
protective measures individuals can or
should take. The purpose of these
communications is to provide
consumers with information so they can
protect themselves from potential health
risks associated with an outbreak or
food recall. Consumers also get
information about an outbreak or recall
from other sources, including other
federal and state agencies, industry,
consumer groups, and the mass media,
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 74, Number 221 (Wednesday, November 18, 2009)]
[Notices]
[Pages 59557-59558]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27688]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB review; Comment Request; Parental Knowledge,
Attitudes, and Behaviors Related to Pediatric Cardiovascular Health
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of Health has submitted to the Office
of Management and Budget (OMB) a request to review and approve the
information collection listed below. This proposed information
collection was previously published in the Federal Register on
Wednesday, July 29, 2009, Volume 74, Number 144 and allowed 60-days for
public comment. No public comments were received. The purpose of this
notice is to allow an additional 30 days for public comment.
5 CFR 1320.5 (General requirements) Reporting and Recordkeeping
Requirements:
Final Rule requires that the agency inform the potential persons
who are to respond to the collection of information that such persons
are not required to respond to the collection of information unless it
displays a currently valid OMB control number. This information is
required to be stated in the 30-day Federal Register Notice.
Proposed Collection: Describe the proposed information collection
activity as follows. Include: Title: Parental Knowledge, Attitudes, and
Behaviors Related to Pediatric Cardiovascular Health; Type of
Information Collection Request: New; Need and Use of Information
Collection: Coinciding with the release of the Integrated Pediatric
Cardiovascular Risk Reduction Guidelines, the National Heart, Lung, and
Blood Institute (NHLBI) will conduct a national public awareness
campaign to help parents understand that risk for cardiovascular
disease (CVD) begins in childhood, and to engage them in encouraging
healthy habits in their children to promote heart health and reduce
their children's CVD risk now and as they grow. Currently, little is
known about parental knowledge, attitudes, and behaviors related to
heart health in children. Serving as a baseline for evaluation of
NHLBI's outreach activities related to the campaign, this study seeks
to learn the following: (a) Parents' awareness of cardiovascular
disease risk factors in children and knowledge of what to do for risk
reduction, (b) parents' level of efficacy toward taking action to
promote cardiovascular health and reduce risk factors, and (c) parents'
behaviors related to cardiovascular health. The findings will provide
valuable information that will enable NHLBI to identify the gaps in
knowledge and awareness and target specific
[[Page 59558]]
information in communications with parents. NHLBI will also be able to
determine parents' efficacy related to the actions needed to promote
their children's heart health, allocating resources for the campaign to
provide support to overcome perceived barriers; Frequency of Response:
One-time survey; Affected Public: Individuals or households; and Type
of Respondents: Parents and caregivers of children ages 0-7. The annual
reporting burden is as follows: Estimated Number of Respondents: 1,175;
Estimated Number of Responses per Respondent: 1; Average Burden Hours
Per Response: .167; and Estimated Total Annual Burden Hours Requested:
196.23. There are no Capital Costs, Operating Costs, and/or Maintenance
Costs to report.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) Evaluate the accuracy of the agency's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Amy Pianalto, National Heart, Lung, and Blood
Institute, NIH, 31 Center Drive, Building 31A, Room 4A10, Bethesda, MD
20892; or call non-toll-free number 301-594-2093 or e-mail request,
including your address, to pianaltoa@nhlbi.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: October 30, 2009.
Amy Pianalto,
Technical Writer, Office of Communications and Legislative Activities,
NHLBI, National Institutes of Health.
[FR Doc. E9-27688 Filed 11-17-09; 8:45 am]
BILLING CODE 4140-01-P
